Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine
Primary Purpose
Migraine, Classic Migraine, Common Migraine
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
topiramate; almotriptan malate
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine headache, Topiramate, Almotriptan malate
Eligibility Criteria
Inclusion Criteria: Have a history of migraine headaches for at least 6 months Experience 3-12 migraines per month Able to take oral medication Able to complete the electronic diary (Personal Digital Assistant-PDA). Exclusion Criteria: You will not be able to participate in the study if you previously discontinued Topiramate or Almotriptan because it did not make you feel better or it made you feel different Have 15 or more headache days a month Experience migraine aura without a headache Already on a migraine preventative medicine.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary effectiveness parameter will be the proportion of subjects in each treatment group who achieve a Sustained Pain Free (SPF) response during the first qualifying headache of the Assessment Period.
Secondary Outcome Measures
For first headache of the Assessment Period, Pain relief at 2 hours; Pain free at 2 hours; Maximum intensity of headache pain; Headache duration; Rescue medication use; Maximum intensity of migraine associated symptoms (photophobia, phonophobia, nausea).
Full Information
NCT ID
NCT00210496
First Posted
September 13, 2005
Last Updated
May 16, 2011
Sponsor
Janssen-Ortho LLC
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00210496
Brief Title
Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine
Official Title
Efficacy of AXERT (Almotriptan Malate) in the Acute Treatment of Migraine: A Pilot Study of the Potential Impact of Preventive Therapy With TOPAMAX (Topiramate)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Janssen-Ortho LLC
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the impact of topiramate (migraine prevention medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating acute migraine headaches.
Detailed Description
Migraine afflicts greater than 28 million adults in the United States. Acute treatments, such as almotriptan malate, target the symptoms of a migraine attack. Preventive treatments, such as topiramate, primarily target the generation of attacks and may decrease use of acute treatments. Preventive treatments, by a process of neurostabilization, may result in an additive effect on almotriptan malate to improve acute treatment intervention response during a migraine attack. This is a randomized, double blind, parallel group multicenter study that will enroll patients 18-65 years old with a history of 3-12 migraine headaches each month for the past 3 months. The total study duration will be approximately 32 weeks. The study is divided into 4 phases as follows: A Screening Phase that lasts one month; An Open Label Phase where all patients will be treated with topiramate gradually dosed to 100mg a day lasting 6 weeks; A Double Blind Phase lasting 19 weeks at which time patients will be randomized to stay on topiramate 100mg per day or switch to placebo topiramate (50:50 chance) and a Taper/Exit Phase lasting 2 weeks. Almotriptan malate will be used for all migraine headaches during the study as needed. The study hypothesis is that the combination of almotriptan malate and topiramate will have a better clinical response than the combination of almotriptan malate and placebo topiramate. Migraine pain information will be collected from each patient with the use of a Personal Digital Assistant (PDA or Palm Pilot) throughout the study for each migraine attack. Commercial Topiramate will be gradually increased to 100mg/day in approximately 4-6 weeks. You will then be randomized to either Topiramate or Placebo, dosed at 100mg a day, for the remainder of the study (18 weeks). AXERT 12.5mg may be taken to treat migraine headaches during the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Classic Migraine, Common Migraine
Keywords
Migraine headache, Topiramate, Almotriptan malate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
406 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
topiramate; almotriptan malate
Primary Outcome Measure Information:
Title
The primary effectiveness parameter will be the proportion of subjects in each treatment group who achieve a Sustained Pain Free (SPF) response during the first qualifying headache of the Assessment Period.
Secondary Outcome Measure Information:
Title
For first headache of the Assessment Period, Pain relief at 2 hours; Pain free at 2 hours; Maximum intensity of headache pain; Headache duration; Rescue medication use; Maximum intensity of migraine associated symptoms (photophobia, phonophobia, nausea).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a history of migraine headaches for at least 6 months
Experience 3-12 migraines per month
Able to take oral medication
Able to complete the electronic diary (Personal Digital Assistant-PDA).
Exclusion Criteria:
You will not be able to participate in the study if you previously discontinued Topiramate or Almotriptan because it did not make you feel better or it made you feel different
Have 15 or more headache days a month
Experience migraine aura without a headache
Already on a migraine preventative medicine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Ortho LLC Clinical Trial
Organizational Affiliation
Janssen-Ortho LLC
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=291&filename=CR002875_CSR.pdf
Description
Acute Treatment of Migraine Impact of Preventive Therapy w/TPM
Learn more about this trial
Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine
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